Anxiety Disorders, Depression
Conditions
Brief summary
The purpose of this research study is to collect information to better understand caregiver responses to COVID-19 stress and to help caregivers of children with Autism Spectrum Disorder (ASD) cope with these stressors.
Interventions
BEHAVIORALUP-Caregiver
The Unified Protocol (UP) is a telehealth group session using Zoom with each session lasting approximately 60-90 minutes. The sessions will focus on a variety of Cognitive Behavior Therapy techniques. These sessions may include teaching coping skills, goal setting, parent-child problem solving and communication, and motivation during this pandemic.
Sponsors
The Children's Trust, Miami FL
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must be willing to consent to participate via RedCap 2. Indicate a mild or greater elevation on screening measures of anxiety and/or depression 3. Not meet any
Exclusion criteria
. 4. Lives in Florida 5. Has a child between the ages of 4-13 years who has been diagnosed with ASD 6. Speaks either English or Spanish primarily 7. Has technical capacity to participate in Zoom sessions on a mobile device or preferably a computer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety levels as measured by GAD-7 | Baseline, 6 Weeks | Parent Psychopathology levels will be reported as the change in the Generalized Anxiety Disorder 7-item (GAD-7) scores. GAD-7 is a 7-item measure assessing the presence and severity of symptoms of anxiety. The Scale has a total score ranging from 0 to 21 with the higher scores indicating greater anxiety. |
| Change in depressive symptoms as measured by the PHQ | Baseline, 6 Weeks | Parent Psychopathology levels will be reported as the change in the Patient Health Questionnaire (PHQ) scores. PHQ is a 9-item measure assessing the severity of depressive symptoms. It has a total score ranging from 0 to 27 with the higher scores indicating greater depressive symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in parenting beliefs as measured by the PSOC Scale | Baseline, 6 Weeks | Parenting Sense of Competence (PSOC) scale is a 17-item measure of parenting self-efficacy and satisfaction. It has a total score ranging from 17 to 102 with the higher scores indicating greater self-efficacy and satisfaction in the parenting role. |
| Change in Hope as measured by the State Hope Scale | Baseline, 6 Weeks | State Hope Scale is a 6-item measure designed to evaluate hope in adults. It has a total score ranging from 6 to 48 with the higher scores representing higher hope levels. |
| Acceptability of Intervention as measured by the Program Feedback Scale | 6 Weeks | The Program Feedback Scale has a total score ranging from 0 to 28 with the higher score indicating perceived acceptability and feasibility of the program. |
Countries
United States
Outcome results
None listed